Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Midwestern Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Pankaj Vashi, MD, Midwestern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01325584
First received: March 25, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.


Condition Intervention
Cancer
Hepatic Injury
Drug: Omegaven

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury

Resource links provided by NLM:


Further study details as provided by Midwestern Regional Medical Center:

Primary Outcome Measures:
  • maximum conjugated bilirubin [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Time to resolution of bilirubin or time to death [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
    to be summarized as incidence and if there is sufficient data may also be presented as time to resolution.

  • average improvement in bilirubin, alkaline phosphatase, AST, and ALT [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
    lab values will be summarized at baseline and as change from baseline to worst follow-up value.

  • Adverse Events reported for each patient [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omegaven (compassionate use)
This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.
Drug: Omegaven
initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.
Other Name: fish oil

Detailed Description:

This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. For patients > 120% ideal body weight, adjusted body weight will be used. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Omegaven will be co-administered via a y-site infusion, with containers being changed every 12 hours. The patient may receive other lipids to meet Essential Fatty Acid (EFA) and/or additional calorie needs. Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. If an adverse reaction is observed, IV steroids & benadryl will be administered & Omegaven will be discontinued. Patients will continue to receive infusions at CTCA for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home with Coram. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month (see Table 2).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female; ages 18 to 80 years old
  2. Receiving treatment at CTCA
  3. Receiving PN (either in the infusion center or at home)
  4. Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary obstruction
  5. Able to provide informed written consent (patient or legally acceptable representative)

Exclusion Criteria:

  1. Hypertriglyceridemia (fasting triglycerides [TG] > 400)
  2. Allergy to fish or egg protein
  3. Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin
  4. Hemodynamically unstable
  5. Bilirubin > 5 mg/dL
  6. Documented progression of liver metastases
  7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening
  8. Recent cardiac infarction taking plavix
  9. Severe hemorrhagic disorders
  10. Embolism
  11. Sepsis
  12. Undefined coma status
  13. Renal insufficiency with calculated creatinine clearance < 30 mL/min
  14. Pregnancy or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325584

Contacts
Contact: Bruce Steinert, PhD 8477311648

Locations
United States, Illinois
Cancer Treatment Centers of America at Midwestern Regional Medical Center Recruiting
Zion, Illinois, United States, 60099
Contact: Bruce Steinert, PhD    847-731-1648    bruce.steinert@ctca-hope.com   
Sponsors and Collaborators
Midwestern Regional Medical Center
Investigators
Principal Investigator: Pankaj Vashi, MD Midwestern Regional Medical Center
  More Information

No publications provided

Responsible Party: Pankaj Vashi, MD, Lead National Medical Director, National Director Gastroenterology, Nutrition & Metabolic Support, Midwestern Regional Medical Center
ClinicalTrials.gov Identifier: NCT01325584     History of Changes
Other Study ID Numbers: MRMC 10-06
Study First Received: March 25, 2011
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014